MedTrace Logo

Power Injectable Versus a Non-Power Injectable, Upper Arm, TIVAD for Chemotherapy

NCT02282449 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 209

Last updated 2016-10-26

No results posted yet for this study

Summary

Patients with cancer often require intravenous chemotherapy for long periods of time.

Ensuring that these patients have safe and reliable access to the veins for chemotherapy is challenging, and sometimes a medical device is required to administer the chemotherapy into the veins.

A totally implanted venous access device, or port, is implanted under the skin of the arm and is attached to a small plastic catheter that enters into the veins. This device can be punctured with a needle when needed for treatment or testing.

Some types of these vein ports can rapidly inject fluids (power injection), and can be used for follow-up imaging studies, such as computed tomography, that are required to follow cancer treatment effectiveness. There are no publications of randomized patients discussing the impact of power injection upon TIVAD complications and device longevity for arm implantation. The investigators propose to compare the effectiveness of power injectable against non-power injectable ports to determine if they have different clinical performance and complications. Our results will impact the care provided to cancer patients.

Conditions

  • Malignancy

Interventions

DEVICE

Power Injectable Port (AngioDynamics Smart Port CT Mini)

The subjects will all receive power injectable port.

DEVICE

Non-Power Injectable Port (Cook Vital Mini Port)

The subjects will all receive non-power injectable port.

Sponsors & Collaborators

  • University of Saskatchewan

    lead OTHER

Principal Investigators

  • Brent E Burbridge, MD, FRCPC · Medical Imaging, 103 Hospital Drive, Royal University Hospital, Saskatoon, SK, Canada S7N 0W8

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02282449 on ClinicalTrials.gov